Agenda Profile: Riina Sikkut

Second reading of the bill amending the Medicines Act (hospital pharmacy) (532 SE)

2025-04-09

15th Estonian Parliament, 5th session, plenary session

Political Position
The speaker strongly supports improving patient access to novel medicines via the hospital exemption route, citing the growing number of cancer cases and Estonia’s small size as a market. Although the compromise proposal in the draft bill is supported, concern is raised that added bureaucracy could prolong processes and impede the quick availability of treatment. The focus remains on patient safety and national innovation, which is presented as a policy- and results-based approach.

3 Speeches Analyzed
Topic Expertise
The speaker demonstrates profound expertise in the fields of medicine and pharmaceutical policy, citing specific statistical data on the growth of cancer cases (e.g., 6,500 cases in 2005 versus 10,000 projected cases). Specific terminology is employed, such as cell therapy, genetic therapy, precision radiotherapy, and cancer genome analysis. The content of the hospital exemption regulation, which stems from the European Union Medicines Directive, and its transposition into Estonian law in 2022 are explained.

3 Speeches Analyzed
Rhetorical Style
The style is professional, analytical, and pragmatic, focusing on logical arguments, data, and the legal framework. The speaker’s tone is concerned, emphasizing the rapid development of medicine and the necessity of trusting specialists and pharmaceutical manufacturers. Simultaneously, a warning is issued against excessive bureaucracy, which could prolong processes, even though the compromise proposal is supported.

3 Speeches Analyzed
Activity Patterns
The speaker was actively engaged in preparing the draft legislation and took part in extensive discussions within the Social Affairs Committee. It is noted that the initiative for this amendment originated with members of the Riigikogu who had approached the speaker directly. This operational pattern demonstrates a clear focus on the specific legislative process and its intricate details.

3 Speeches Analyzed
Opposition Stance
The direct opposing party is not criticized, but concern is expressed regarding their procedural additions (such as ethics committee stages) which may increase bureaucracy. The criticism is aimed at the fact that these additional barriers prolong the process in a situation where there is insufficient competence for proper oversight, thereby impeding access to timely treatment.

3 Speeches Analyzed
Collaboration Style
The speaker stressed the wide-ranging cooperation, noting that the initiative for the draft legislation originated in the Riigikogu and was prepared in collaboration with numerous relevant stakeholders. Thanks were extended to the Social Affairs Committee for their thorough deliberation, and the compromise proposal is being accepted, even though it is not viewed as an ideal solution.

3 Speeches Analyzed
Regional Focus
The focus is on Estonian patients and national scientific development, emphasizing that Estonia is a small, unattractive market requiring special measures. The goal is to ensure that people receive the best possible treatment domestically and to create development opportunities for Estonian hospitals, universities, and businesses. The international context (the EU directive) is also mentioned.

3 Speeches Analyzed
Economic Views
Support is provided for the development of innovative, high-tech treatment methods in Estonia, viewing the hospital exemption as a growth opportunity for both hospitals and enterprises. Emphasis is placed on the need to reduce the administrative burden and shorten procedural deadlines (from 120 days to 90 days), which signals a focus on efficiency and the promotion of innovation.

3 Speeches Analyzed
Social Issues
The primary social focus centers on public health and the protection of patients' interests, especially regarding cancer treatment and the accessibility of new medicines. It is emphasized that patient safety and interests must be paramount, and the goal is to offer people the best possible treatment in Estonia.

3 Speeches Analyzed
Legislative Focus
The primary legislative focus is on amending the Medicines Act concerning the hospital exemption, in order to enable the preparation of novel medicines for specific Estonian patients. The speaker is an active proponent and drafter of the bill, aiming to reduce administrative burden and shorten permit issuance deadlines.

3 Speeches Analyzed